Senior Quality Assurance Executive - Toa Payoh

Overview:

The role focuses on the development and maintenance of overall Quality Management System (QMS) of the company.

Key Responsibilities:

• Implement of both existing and new ISO 13485 and GxP regulations as well as any other relevant standards for company’s Quality Management System (QMS) and maintain employees’ awareness of regulatory trends in industry and implementing necessary changes in QMS.
• Attain new and maintain existing business licenses and certifications included but not limited to GDP, ISO 9001, ISO 13485 etc. and maintain business license and certification tracker.
• Liaise with regulatory and certification bodies and internal stakeholders to ensure that QMS processes and activities, including sales, contract manufacturing, storage and distribution of goods etc are in compliance with local and where applicable international regulations, codes and standards.
• Develop procedures and maintain QMS documentation through effective document control and manage cross functional documentation development, review and revision.
• Prepare and conduct Management review and follow up with action items for closure.
• Conduct internal training on quality related topics and QMS processes to relevant staff.
• Review both customer and supplier quality agreements and handle tender enquiries where required.
• Identify QMS process gaps and collaborate with internal stakeholders where applicable to implement solutions for resolution.
• Provide monthly QA KPI and compliance reporting to management on business and manufacturing plant’s operations including cases of any non- accordance with ISO 13485 and GxP guidelines.
• Ensure all aspects of product contract manufacturing, storage and distribution are performed in accordance with regulatory requirements, local quality standards and company regulations.
• Establish, communicate and implement internal audit programme and conduct audits and follow up with stakeholders to ensure audit findings closure.
• Coordinate and manage external audits from customers, supplier and regulatory bodies etc.
• Plan and conduct site inspection of sales, storage and distribution facility including review of business process and address process non-conformances where appropriate.
• Handle and manage complaints, recall, deviations, CAPA, incidents of counterfeiting and tampering, supplier performance and other relevant quality performance measures and ensure they are raised, investigated, reported, trended and communicated to those required stakeholders and management.
• Track yearly quality related KPIs and objectives and ensure necessary actions to achieve KPI targets and follow up on any shortfalls.
• Handle regulatory queries and assist in product registrations or permit applications where applicable.
• Manage product registrations and business license tracker where required.

Qualifications:

• Education: Bachelor’s degree in quality management, life sciences, engineering, or a related field.
• Experience: Minimum of 3 years of QA experience in ISO 9001, ISO 13485 or GxP (e.g. Good Distribution Practice) for at least one of the preferred categories or equivalent i.e. medical device, single use devices, microbiology diagnostics, or a related industry
• Regulatory Knowledge: Strong understanding of ISO 9001, 13485, GMP, GDP and other relevant regulatory requirements. Experience with regulatory inspections and audits is essential. Lead auditor qualification in ISO 9001, ISO 13485 is preferred.
• Skills:
• Strong analytical and problem-solving skills.
• Excellent communication and leadership skills.
• Familiarity with risk management principles and quality improvement methodologies.
• Certifications: Quality management certifications (e.g., Certified Quality Auditor
• CQA, Certified Quality Manager
• CQM) are a plus.
• Only Singaporeans may apply.
• Fluent in both written and oral English